Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00361933
Status:
WITHDRAWN
Last Update Posted:
2017-04-18
First Post:
2006-08-08
Brief Title:
Valganciclovir to Treat HHV-8 Associated Multicentric Castlemans Disease
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Clinical and Virologic Response to HHV-8 Associated Multicentric Castlemans Disease to Valganciclovir
Status:
WITHDRAWN
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Research never begun
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to learn whether people who are experiencing an MCD multicentric Castlemans Disease flare will improve after taking valganciclovir MCD is a type of inflammatory disease associated with Human Herpesvirus 8 HHV-8 Valganciclovir is FDA approved for treating a different type of Human Herpesvirus but not approved for the treatment of HHV-8 It is therefore considered experimental in this study
Detailed Description:
All participants will undergo an initial screening appointment At this visit participants will be tested for Human Herpesvirus 8 HHV-8 the virus that is associated with MCD and we will review participants medical history and medical records to determine whether heshe has MCD If participants do not live within the Seattle area this visit may occur over the phone
Those who qualify for the study will be followed for up to 2 years During that 2 year period participants will be asked to collect oral swabs once a week and have blood drawn monthly If subjects do not live within the Seattle-area they will be asked to ship these samples to UW for testing We will provide subjects with instructions for these shipments This will be done at no cost to the participant
If during the 2 year period the participant experiences a MCD flare heshe will be admitted to the University of Washington Medical Centers Clinic Research Center for 14-days If the participant does not live within the Seattle-area all travel expenses will be covered
The study will enroll a total of 8 patients who will receive open-label valganciclovir for 14-days Everyday during the hospitalization participants will have blood drawn to check your HHV-8 levels 1 oral swab will be collected and a general physical exam will be performed
Those who qualify for the study will be followed for up to 2 years During that 2 year period participants will be asked to collect oral swabs once a week and have blood drawn monthly If subjects do not live within the Seattle-area they will be asked to ship these samples to UW for testing We will provide subjects with instructions for these shipments This will be done at no cost to the participant
If during the 2 year period the participant experiences a MCD flare heshe will be admitted to the University of Washington Medical Centers Clinic Research Center for 14-days If the participant does not live within the Seattle-area all travel expenses will be covered
The study will enroll a total of 8 patients who will receive open-label valganciclovir for 14-days Everyday during the hospitalization participants will have blood drawn to check your HHV-8 levels 1 oral swab will be collected and a general physical exam will be performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| VAL096 | None | None | None |